13 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4
FDA 510(k)
FDA Class 1
·Dental
Valencia Pedicle Screw System
FDA UDI
Altus Spine, LLC·00843210134727·6.5mm Pedicle Tap, Cannulated
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450210406·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450216705·
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
GAS MODULE III
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC·Product code BZK·April 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY
FDA Adverse Event
Malfunction
·COOK, INC.·Product code MIH·May 12, 2011
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012